Assessing booster responses to routine immunisation in infants

• Research type

  Research Study

• Full title

  A prospective study to evaluate the immune responses of UK infants to their routine 12-month booster vaccines following receipt of different meningococcal capsular group C (MenC) conjugate vaccines as part of their primary immunisation schedule

• IRAS ID

  114372

• Contact name

  Elizabeth Miller

• Sponsor organisation

  Public Health England

• Eudract number

  2012-005110-18

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  The UK national immunisation schedule is updated regularly as new vaccines are licensed so that the best protection is offered to infants and young children. Currently, in addition to diphtheria, tetanus, pertussis (whooping cough) and polio, infants are also vaccinated against the pneumococcus, Hib and Meningococcal C (MenC) bacteria, which are major causes of serious bacterial infections in early childhood, including meningitis, septicaemia (blood poisoning) and pneumonia. The vaccines against these three bacteria were developed by linking (or conjugating) their outer sugar capsules to a carrier protein, such as inactivated tetanus or diphtheria toxin. Unlike polysaccharide vaccines (which are made of the bacterial sugar capsule only and provide limited, short-term immunity in older children and adults only), conjugated vaccines are able to induce very high antibody levels in infants as young as 2 months old. Currently, all infants in the UK receive the same pneumococcal (Prevenar13) and Hib-containing (Pediacel) vaccines, but can receive any one of 3 licensed MenC vaccines which contain different conjugate proteins (NeisVac-C contains tetanus toxoid, while Menjugate and Meningitec contain inactivated diphtheria toxin), depending on which vaccine stock the GP surgery have acquired from the Department of Health at the time. We have recently found that the immune responses of infants to MenC as well as Hib when measured at 5 months (1 month after completing their infant schedule) depends on the conjugate protein in the MenC vaccine. Because all infants receive a booster dose of both MenC and Hib vaccines at 12 months of age, it is likely that they will all develop adequate long-term protection against these infections. In order to verify this, however, we would like to check the immune responses of infants just before and one month after they receive their 12-month booster vaccines.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/1875

• Date of REC Opinion

  7 Dec 2012

• REC opinion

  Favourable Opinion